New life-saving treatments for Heart failure in clinical trial on A multicenter, randomized, double-blind, placebo-controlled phase III study to evaluate the efficacy, safety and tolerability of Serelaxin when added to standard therapy in acute heart failure patients
The NIH National Institute of Neurological Disorders and Stroke (NINDS...The double-blind placebo-controlled phase III study is one of the la... This study is an important step toward developing a therapy that coul...The trial is the first large study in a series of NINDS-sponsored clin... This study is an example of the Institutes commitment to Parkinsons...,NIH,announces,phase,III,clinical,trial,of,creatine,for,Parkinsons,disease,biological,biology news articles,biology news today,latest biology news,current biology news,biology newsletters
Stockholm, Sweden, November 30, 2009. Swedish drug development today announced the preliminary results of its phase II clinical trial of , an orally administere
This study is investigating the efficacy of tumour cell vaccine GVAX in patients with advanced myelodysplastic syndrome or acute myeloid leukemia undergoing
Efficacy and Safety of AM-101 in the Treatment of Acute Inner Ear Tinnitus - A Double-Blind, Randomized, Placebo-Controlled Phase III Study. Tobias Kleinjung, Tony Cox, Ingeborg Dhooge, Wojciech Domka, Roger Fischer, Marie José Fraysse, José Ramon Garcia-Berrocal, Grażyna Gawlicka, Andrea Kienle-Gogolok, Marianne Grohé, Florian Heimlich, Andreas Horn, Andrzej Krzyzaniak, Elisabeth Kühne, Piotr lach, Balint Liktor, Grażyna Lisowska, Guido Mühlmeier, Michel Paolino, Christof Pauli, Tamas Racz, Deepak Rajenderkumar, Paul van de Heyning, Thomas Meyer. ...
Somatropin is a polypeptide hormone consisting of 191 amino acid residues and its structure is identical to that of growth hormone extracted from human pituitary glands.The clinical efficacy of SEROSTIM (somatropin for injection) was assessed in a short term metabolic study and two placebo-controlled Phase III clinical trials.Patients completing 12 weeks of treatment were eligible to receive open-label SEROSTIM therapy.
This study is investigating the safety, tolerability and pharmacokinetics of single and multiple ascending doses of ZYAN1 in healthy volunteers. Part I includes
BOUDRY, Switzerland--(BUSINESS WIRE)--Jun. 14, 2013-- Celgene International Sàrl, a subsidiary of Celgene Corporation (NASDAQ: CELG) today presented results from a randomized, placebo-controlled phase II...
Research - Open Access Eulalia Jimenez, Carol Astbury, Muna Albayaty, Ulrika Wählby-Hamrén, Beatriz Seoane, Cristina Villarroel, Helena Pujol, Maria Jesus Bermejo, Ajay Aggarwal & Ioannis Psallidas Respiratory Research volume 21, Article number: 211 (2020) Abstract Background ...
In this randomized, double-blind, placebo-controlled phase II trial to examine the effect of Polyphenon E [containing the most important polyphenol, epidgallocatechin gallate (EGCG) in green tea] on endogenous hormone profiles, 111 participants were recruited and randomized into three different experimental arms: 400 mg EGCG daily, 800 mg EGCG daily or placebo for a period of 60 days. Four steroid hormones: androstenedione (Andr), testosterone (T), estrone (E1) and estradiol (E2), and two protein hormones: adiponectin (Adip) and insulin-like growth factor 1 (IGF1), plus two hormone binding proteins: IGF binding protein 3 (IGFbp3) and sex hormone binding globulin (SHBG) levels were measured at baseline, at end of month-1 and at end of month-2. This study failed to provide confirmatory evidence of lower serum E1 and E2 values due to green tea consumption. The E1 and E2 values declined in the group treated with EGCG but similar declines were also seen in the placebo group. The only treatment effect ...
Initial cytoreductive surgery followed by 6 cycles of platinum-taxane based chemotherapy (Cx) remains the standard of care for advanced OC. For those patients for whom complete resection is deemed difficult to achieve, IDS after 3 cycles of NACx and followed by 3 others cycles represents an alternative strategy.. Three antiangiogenic drugs (AAD) have been shown to be active and to prolong progression-free survival (PFS) in first-line treatment of OC after initial debulking surgery: bevacizumab (BEV, GOG218&ICON7), nintedanib (NIN, OVAR12) and pazopanib (PAZ, OVAR16). In the setting of NACx, none of these drugs have been tested in a randomized trial despite the potential ability of AAD to increase Cx activity and complete surgical resection rate. NIN offers the advantage of being able to be safely combined with Cx and to have a short half-life (7-19 hours) allowing a rapid clearance of the drug before IDS. ...
1. No vaccine has ever been evaluated through a double blind, placebo controlled study to determine if it actually has any preventive or mitigating effect on the disease of interest. A) As you know, being a doctor, double-blind placebo-controlled trials are not the only way to study medicines. B) See above: vaccines are indeed tested through double-blind placebo-controlled trials. Granted, they dont deliberately expose everyone to the pathogen (at least, not any more) as deliberately killing people is frowned upon. Instead, they make sure the vaccine does what it was meant to do: produce the right antibodies.. 2. Epidemiologists can successfully predict pandemics, epidemics and outbreaks of any given disease by tracking vaccination programs: the larger the program, the more widespread the outbreak of the disease.. This is true in certain circumstances, and the reason for this is very interesting. When a disease is endemic, cases are usually (though not always) mild, and nearly everyone gets ...
TY - JOUR. T1 - First and subsequent cycle use of pegfilgrastim prevents febrile neutropenia in patients with breast cancer. T2 - A multicenter, double-blind, placebo-controlled phase III study. AU - Vogel, Charles. AU - Wojtukiewicz, Marek Z.. AU - Carroll, Robert R.. AU - Tjulandin, Sergei A.. AU - Barajas-Figueroa, Luis Javier. AU - Wiens, Brian L.. AU - Neumann, Theresa A.. AU - Schwartzberg, Lee S.. PY - 2005/2/20. Y1 - 2005/2/20. N2 - Purpose: We evaluated the efficacy of pegfilgrastim to reduce the incidence of febrile neutropenia associated with docetaxel in breast cancer patients. Patients and Methods: Patients were randomly assigned to either placebo or pegfilgrastim 6 mg subcutaneously on day 2 of each 21-day chemotherapy cycle of 100 mg/m2 docetaxel. The primary end point was the percentage of patients developing febrile neutropenia (defined as body temperature ≥ 38.2°C and neutrophil count , 0.5 × 109/L on the same day of the fever or the day after). Secondary end points were ...
Certolizumab pegol in combination with dose-optimised methotrexate in DMARD-naïve patients with early, active rheumatoid arthritis with poor prognostic factors: 1-year results from C-EARLY, a randomised, double-blind, placebo-controlled phase III study Academic Article ...
Efficacy and Safety of AM-101 in the Treatment of Acute Inner Ear Tinnitus - A Double-Blind, Randomized, Placebo-Controlled Phase III Study. Tobias Kleinjung, Tony Cox, Ingeborg Dhooge, Wojciech Domka, Roger Fischer, Marie José Fraysse, José Ramon Garcia-Berrocal, Grażyna Gawlicka, Andrea Kienle-Gogolok, Marianne Grohé, Florian Heimlich, Andreas Horn, Andrzej Krzyzaniak, Elisabeth Kühne, Piotr lach, Balint Liktor, Grażyna Lisowska, Guido Mühlmeier, Michel Paolino, Christof Pauli, Tamas Racz, Deepak Rajenderkumar, Paul van de Heyning, Thomas Meyer. ...
Objectives Surveys in various countries suggest 17% to 80% of doctors prescribe placebos in routine practice, but prevalence of placebo use in UK primary care is unknown. Methods We administered a web-based questionnaire to a representative sample of UK general practitioners. Following surveys conducted in other countries we divided placebos into pure and impure. Impure placebos are interventions with clear efficacy for certain conditions but are prescribed for ailments where their efficacy is unknown, such as antibiotics for suspected viral infections. Pure placebos are interventions such as sugar pills or saline injections without direct pharmacologically active ingredients for the condition being treated. We initiated the survey in April 2012. Two reminders were sent and electronic data collection closed after 4 weeks. Results We surveyed 1715 general practitioners and 783 (46%) completed our questionnaire. Our respondents were similar to those of all registered UK doctors suggesting
|p|The brain can heal the body: thats the remarkable truth behind the bodys placebo response. As one of the nations foremost authorities on the mysterious connection between mind and body, Dr. Howard Brody introduces a radical new understanding of this phenomenon -- and how it can be used to foster good health. The body, says Brody, has an inner pharmacy that the brain taps into, according to what we anticipate, how we are conditioned by experience, and how we interpret events. Consider the following:In one study, people with allergies showed no response when exposed to the irritant, when they were first convinced it was something. Sham surgery has sometimes produced lasting results, indistinguishable from the results of real operations.Patients recover faster from surgery when they have window views of trees or grass, rather than brick walls.|/p||p|But the placebo response is more than an astonishing medical fact -- it can be put to practical use. |em|The Placebo Response|/em| gives you access to
Karlan BY, Oza AM, Richardson GE, Provencher DM, Hansen VL, Buck M, Chambers SK, Ghatage P, Pippitt CH Jr, Brown JV 3rd, et al. Randomized, double-blind, placebo-controlled phase II study of AMG 386 combined with weekly paclitaxel in patients with recurrent ovarian cancer. J Clin Oncol. 2011;30(4):362-371 ...
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I agree that correlation does not imply causation, but this is often assumed. The only way to tell in these cases is to do a double-blind placebo-controlled trial. I read somewhere that Omega-3 does have some benefit for autistic children, but thats probably just because Omega-3 is good for you. Theres no evidence of brain damage or malfunction across the board in autism. In fact, more recent evidence suggests its simply low socio-linguistic intelligence coupled with high visio-spatial intelligence. ...
To examine key methodological considerations for using a placebo intervention in randomised controlled trials (RCTs) evaluating invasive procedures, including surgery....
Hi, I have been wondering the last week or so regarding the placebo effect. There is lots of material where they talk of the 30% or so of unwarranted improvement people get on sham treatments (ie the placebo arm of ...
Learn more about Double-blind, Placebo-controlled Study at Memorial Health The best and most reliable form of research is the double-blind, placebo-controlled study...
Learn more about Double-blind, Placebo-controlled Study at Memorial Health The best and most reliable form of research is the double-blind, placebo-controlled study...
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies. ...
After finding that $80 of the drug AZT will cut in half the transmission of AIDS from mothers to their newborns, Government health officials are canceling heavily criticized overseas studies that left some pregnant women with the disease receiving only ineffective dummy pills.. The announcement by the Centers for Disease Control and Prevention won immediate approval from defenders of the studies financed by the Government because the findings provide great hope for many developing nations that have been devastated by AIDS. It was also praised by critics of the studies, who had said using dummy pills was unethical.. Article, page A16.. Continue reading the main story ...
The internal validity of double-blinding in randomised placebo-controlled trials (RCT) has become a target of criticism. In several studies, the accuracy of patients and physicians guesses as to the assigned treament was striking.
BACKGROUND: Tobacco smoking is common in people living with HIV, but high-quality evidence on interventions for smoking cessation is not available in this population. We aimed to assess the efficacy and safety of varenicline with counselling to aid smoking cessation in people living with HIV. METHODS: The ANRS 144 Inter-ACTIV randomised, parallel, double-blind, multicentre, placebo-controlled phase 3 trial was done at 30 clinical hospital sites in France. People living with HIV who had smoked at least ten cigarettes per day for 1 year or longer, were motivated to stop smoking, were not dependent on another psychoactive substance, and had no history of depression or suicide attempt were eligible ...
BACKGROUND: Tobacco smoking is common in people living with HIV, but high-quality evidence on interventions for smoking cessation is not available in this population. We aimed to assess the efficacy and safety of varenicline with counselling to aid smoking cessation in people living with HIV. METHODS: The ANRS 144 Inter-ACTIV randomised, parallel, double-blind, multicentre, placebo-controlled phase 3 trial was done at 30 clinical hospital sites in France. People living with HIV who had smoked at least ten cigarettes per day for 1 year or longer, were motivated to stop smoking, were not dependent on another psychoactive substance, and had no history of depression or suicide attempt were eligible ...
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Prot# 01-04-TL-242-011: A Pivotal, Multicenter, Multinational, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TAK-242 in Adults with Severe ...
This study will be a Phase 3, randomized, three-cycle, double-blind, placebo-controlled, parallel group, multiple-dose design.. The study design has four phases: Screening Period; Open-Label Estrogen-Priming Period (Run-In Period); Blinded Treatment Period; and Follow-Up. The Open Label Priming Period and Blinded Treatment Period cover a total of three 28-day cycles. Clinical evaluations will be performed at the following time points:. Screening Period:. • Screening Period (approximately 42 Days). Open-Label Estrogen Priming Period (Run In Period):. ...
Is it possible to heal by thought alone, without drugs or surgery? The truth is that it happens more than you might expect. Discover how to utilize practical applications of the so-called placebo effect so that you can ...
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Placebos are supposed to be inert controls, designed to prove a drugs efficacy. Consequently, placebo composition is rarely documented in drug trials. Is this dangerous?
Methodologically, mITT evaluation could overestimate the remedy influence in case of many fall-out individuals in placebo arms. On the opposite, PP examination
TY - JOUR. T1 - Evaluation of nimodipine in the treatment of severe diffuse head injury. T2 - A double-blind placebo-controlled trial. AU - Pillai, Shibu V.. AU - Kolluri, V. R S. AU - Mohanty, Aaron. AU - Chandramouli, B. A.. PY - 2003/9. Y1 - 2003/9. N2 - Aims: The aim of this study was to establish whether nimodipine given orally soon after severe diffuse head injury for a period of three weeks improved outcome. Material and methods: The present report analyzes the results of a prospective randomized double-blind placebo-controlled trial of nimodipine in 97 severe head injury patients (GCS Score ,\=8) treated at the Department of Neurosurgery, NIMHANS, between January 1995 and June 1996. The patients were randomly assigned to two groups which were matched for age, sex, mode of injury, time interval from injury to admission, neurological status and CT scan findings. One group was given nimodipine 30 mg Q6H and the other group was given a placebo. The outcome of these patients at 6 months was ...
Clinical trial for Warm Antibody Autoimmune Hemolytic Anemia , A Phase 3 Multi-Center Randomized Double-Blind Placebo-Controlled Study of Fostamatinib Disodium in the Treatment of wAIHA
A Phase 3 Multicenter Multinational Randomized Double-blind Placebo-controlled Study to Evaluate the Efficacy and Safety of Patisiran (ALN-TTR02) in Transthyretin (TTR)-Mediated Polyneuropathy (Familial Amyloidotic Polyneuropathy - FAP) (APOLLO)
Tay, H.H., Yap, I., Guan, R., Koh, P.S.S., LaBrooy, S.J., Kang, J.Y. (1988). Twice daily cimetidine in the initial treatment of chronic gastric ulcer - A double-blind placebo-controlled trial. Medical Journal of Malaysia 43 (2) : 181-185. [email protected] Repository ...
i.e., soft or watery) stools and >200 g of abnormal stool weight over a 24-h period. Subjects discontinued all antidiarrheal agents >24 h before enrollment. Stool samples were studied for routine pathogens. Subjects received 500 mg p.o. of SP-303 or placebo every 6 h for 96 h (4 days). Stool frequency and weights were recorded. Subjects were monitored for symptoms and side effects and were seen 1 wk later in follow-up. RESULTS: A total of 26 subjects received SP-303, and 25 received placebo. There were no significant demographic differences between treatment arms. A total of 41 subjects (80%) were receiving antiretroviral therapy and 39 subjects (77%) were receiving at least one protease inhibitor. Stool studies revealed no pathogens in 48 of 51 patients (94%). There were no serious adverse events or laboratory abnormalities. The SP-303 treatment group demonstrated a mean reduction from baseline stool weight of 451 g/24 h versus 150 g/24 h with placebo on day 4 of treatment (p = 0.14), and a ...
Subcutaneous interferon beta-1a is an effective treatment for relapsing/remitting MS in terms of relapse rate, defined disability, and all MRI outcome measures in a dose-related manner, and it is well tolerated. Longer-term benefits may become clearer with further follow-up and investigation.
As reported in this issue of The ASCO Post, Robert and colleagues recently published a phase III study comparing the anti-programmed death 1 (PD-1) antibody nivolumab with the standard melanoma chemotherapy dacarbazine in the front-line treatment of patients with advanced BRAF wild-type melanoma.1 In this study, nivolumab was shown to be superior to dacarbazine in improving overall survival, progression-free survival, and objective response rate. Nivolumab was also associated with a lower rate of high-grade side effects than dacarbazine. Of importance, this study is the first to demonstrate that nivolumab, and any anti-PD-1 antibody, improves overall survival compared with a standard comparator in a large, well-conducted, randomized, placebo-controlled phase III study.. The high response rate and favorable toxicity profile of nivolumab and pembrolizumab (Keytruda), another anti-PD-1 antibody, in patients with melanoma have been well known from large, previously published, early-phase studies.2-5 ...
A medication may have several effects on a patient. Some effects may be directly related to the medications effect on the bodys functioning or physiology (this is called the pharmacological effect of a medication). Another effect of a medication may not be linked directly to the medicines pharmacological effect. This is called the placebo effect. A placebo effect can be observed when a pharmacologically inert (inactive) substance (usually in the form of a pill) is administered. What is the placebo effect? What does the placebo effect have to do with the process of developing new treatments or new medications in controlled clinical trials? What is the importance of the placebo effect to clinical trials in Parkinsons disease?. The word placebo comes from the Latin verb "placere," that means, "to please." Placebo is an inactive treatment. Placebo effect is the effect on a subject (usually beneficial) resulting from the administration of a placebo. When a patient receives any treatment (whether ...
Hoeger K, Davidson K, Kochman L, et al: The impact of metformin, oral contraceptives, and lifestyle modification on polycystic ovary syndrome in obese adolescent women in two randomized, placebo-controlled clinical trials, J Clin Endocrinol Metab 2008(Nov);93(11):4299-306 (PMID 18728175). Sathyapalan T, Kilpatrick ES, Coady AM, Atkin SL: The effect of atorvastatin in patients with polycystic ovary syndrome: A randomized double-blind placebo-controlled study, J Clin Endocrinol Metab 2009(Jan);94(1):103-8 (PMID 18940877). Chlebowski RT, Kuller LH, Prentice RL, et al: Breast cancer after use of estrogen plus progestin in postmenopausal women, N Engl J Med 2009(Feb);360(6):573-87 (PMID 19196674). The Practice Committee of the American Society for Reproductive Medicine: Obesity and reproduction: An educational bulletin, Fertil Steril 2008(Nov);90(5 Suppl):S21-9 (PMID 19007633). [Please contact the library and we will be happy to request a copy of this article for you.]. Dovey S, Sneeringer RM, ...
data cut off date, 45% of cabozantinib-treated and 13% of placebo-treated patients were still receiving study treatment. 60% of placebo-treated patients discontinued treatment for progressive disease, compared with 26% of cabozantinib-treated patients. 16% of patients on the cabozantinib arm had discontinued treatment for an AE compared to 8% of patients on the placebo arm. 5% of patients on both arms discontinued for death. 12% of patients on the placebo arm discontinued study treatment because of subject request compared to 4% on the cabozantinib-treated arm. Safety Results The safety analysis included the 323 patients in both arms of the trial who had received at least one dose of study treatment (214 in the cabozantinib arm and 109 in the placebo arm). Consistent with the much longer PFS, the median duration of exposure was twice as long in the cabozantinib arm (6.7 months) versus the placebo arm (3.4 months). Overall AE results for the trial are consistent with a long duration of exposure ...
Buy or Rent Placebo Effect 165 Success Secrets - 165 Most Asked Questions On Placebo Effect - What You Need To Know as an eTextbook and get instant access. With VitalSource, you can save up to 80% compared to print.
Merck has been testing a candidate HIV vaccine in two large phase II clinical trials; the STEP study in North and South America, the Caribbean and Australia, and a parallel study called Phambili in South Africa. STEP was a multi-center, randomized, double-blind, placebo-controlled phase II test-of-concept clinical trial. Started in December 2004, enrollment in the study was completed by March 2007 and more than 2,500 participants had received all three doses of vaccine or placebo. STEP was evaluating two primary efficacy endpoints ...
TUSTIN, CA--(Marketwired - Jun 3, 2013) - Peregrine Pharmaceuticals (NASDAQ: PPHM), today reported final data from its randomized, double-blind, placebo-controlled Phase II trial of bavituximab in patients with second-line non-small cell lung cancer (NSCLC). Final results from the Phase II trial showed an improvement in median overall survival (OS) of...